SUPPLY CHAIN ARTICLES
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![Game Strategy-GettyImages-169983235]( "Inside Alnylam's Playbook For High Volume siRNA Production")
Inside Alnylam's Playbook For High Volume siRNA ProductionAs one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.
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![Wheel spinning with various prizes-GettyImages-2164166010]( "The Price Is… Almost Right: mRNA Edition! COGS Reduction Strategies")
The Price Is… Almost Right: mRNA Edition! COGS Reduction StrategiesThe following article will outline the current state of COGS in the mRNA industry and the work he and his colleagues undertook to more effectively utilize raw materials. But heaven forbid this be your normal conference panel write-up. No, below I share Parrella’s insights, but in the form of a never-before released episode of The Price is Right…or perhaps more fittingly given the state of the industry today, this spectacle is more aptly titled: The Price is…Sort Of, Almost, Not Quite Right!
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![Talimogene laherparepvec vaccine-GettyImages-960686030]( "Addressing Challenges In Serialization For Complex Therapeutics")
Addressing Challenges In Serialization For Complex TherapeuticsThe magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
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![Key takeaways-GettyImages-1659816694]( "Plasmid Production: 3 Key Takeaways For mRNA Manufacturing")
Plasmid Production: 3 Key Takeaways For mRNA ManufacturingFollowing my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid.
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![Cell transfection with plasmid GettyImages-1290924802]( "Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why")
Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's WhyThe demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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![Helping Hand-GettyImages-1314188794]( "Multidisciplinary mRNA: What Can We Learn From Other CGTs?")
Multidisciplinary mRNA: What Can We Learn From Other CGTs?Overall, there are four high-level best practices/mindsets I proposed during a recent presentation that I believe will be crucial for us to bring some talented RNA therapeutic role models to the forefront. But there is one best practice that I think is worth emphasizing more than the others.
SUPPLY CHAIN VIDEOS
This Advancing RNA Live clip dives into the biggest challenges in mRNA purification and the critical debate on where to focus investment. Here, our three mRNA PD experts argue for a holistic process development strategy, challenging the traditional wisdom of optimizing the upstream process at any cost.
While we can make lots of mRNA at a smaller scale, when it comes to scaling up to kg quantities of mRNA, our current batch processes leave a lot to be desired. Together, Stu Sundseth of Tune Therapeutics and Christian Dohmen of Ethris unpack the biggest barriers to scaling IVT to achieve the desired yield and quality of mRNA, offering their take on how the field is innovating to overcome these issues.
Discover how regional manufacturing, risk-aware practices, and agile strategies are reshaping supply chains to deliver resilience, transparency, and sustainability in today’s complex global environment.
Learn more about CustomBiotech's mRNA raw materials pipeline and strict quality criteria that are designed to support the success of our customers’ manufacturing scale-up and regulatory drug approval.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![clinical-trial-supply-challenges-GettyImages-2161372208]( "Biopharma Supply, Reimagined: Regional, Resilient Manufacturing")
Persistent disruption is redefining biopharma supply chains. Explore how regional manufacturing, integrated risk management, and closer collaboration help build resilience and improve agility.
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![DNA molecules 450x300]( "Chromatographic Purification Of Plasmid DNA")
Widespread application of pDNA in gene therapy is driving increased demand and as a response, plasmid manufacturing must become more efficient with improved productivity. Intensification of chromatographic steps can help address this demand and has led to an exploration of the use of convective media (monoliths, membranes, fibre based technologies).
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![Developing mRNA Vaccines GettyImages-1307593959]( "Consolidating The Supply Chain For mRNA")
Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.
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![iStock-1155553590-syringe-glove-doctor-vaccine-medicine]( "Overcome Vaccine Development Complexities With The Right Supply Chain Partner")
Explore the challenges impacting clinical supply chains and solutions to overcome these complexities, and understand why it is crucial to pick the right supply chain provider for vaccine storage and distribution.
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![Scientists laboratory pipette GettyImages-621351044]( "Eliminating Antibiotic Resistance Gene Transfer Risks In CGTs")
Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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![GettyImages-1409734937 RNA polymerase]( "RNA Polymerases For Efficient mRNA Manufacturing")
Precise enzyme selection in IVT reduces dsRNA byproducts and boosts capping efficiency. This ensures high-quality mRNA production while easing the burden of complex downstream purification processes.
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![GettyImages-1059548518 global conntection]( "The Key To Improving Global Supply Chain Resilience")
Explore the past, present, and future of supply chain security, ways the biopharma industry can secure supply chains and minimize risks, and more.
